Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., April 15, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

    --  The FDA issued two new emergency use authorizations (EUAs) for serology
        tests to detect for the presence of coronavirus antibodies. The EUAs
        were issued to Ortho-Clinical Diagnostics, Inc. for its VITROS
        Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Chembio
        Diagnostic Systems, Inc. for its DPP COVID-19 IgM/IgG System.
    --  The FDA issued an emergency use authorization (EUA) for the emergency
        use of Stryker Instrument's Sterizone VP4 Sterilizer1 N95 Respirator
        Decontamination Cycle for use in decontaminating compatible N95 and
        N95-equivalent respirators for single-user reuse by healthcare
    --  The FDA has posted a new "At-a-Glance Summary" that captures the
        agency's major activities in the fight against COVID-19. The agency
        intends to regularly update this resource on efforts related to medical
        products and equipment, vaccines and therapeutics, food supply and more.
    --  Yesterday, the FDA issued guidance on digital health devices for
        treating psychiatric disorders to help expand the availability of these
        devices while reducing user and health care provider contact and
        potential exposure to COVID-19 during this pandemic. The enforcement
        policy described in the guidance applies to computerized behavioral
        therapy devices and other digital health therapeutic devices for
        psychiatric disorders as well as low-risk general wellness and digital
        health products for mental health or psychiatric conditions.
    --  The FDA and Federal Trade Commission (FTC) issued a warning letter to
        one company for selling fraudulent COVID-19 products, as part of the
        agency's effort to protect consumers. The seller warned, Earth Angel
        Oils, offers essential oil products that are unapproved and misbranded
        drugs for the prevention and treatment of COVID-19. There are currently
        no FDA-approved products to prevent or treat COVID-19. Consumers
        concerned about COVID-19 should consult with their health care provider.
    --  Diagnostics update to date:
        --  During the COVID-19 pandemic, the FDA has worked with more than 315
            test developers who have said they will be submitting emergency use
            authorization (EUA) requests to FDA for COVID-19 tests.
        --  To date, 36 emergency use authorizations have been issued for
            COVID-19 tests.
        --  The FDA has been notified that more than 190 laboratories have begun
            testing under the policies set forth in our COVID-19 Policy for
            Diagnostic Tests for Coronavirus Disease-2019 during the Public
            Health Emergency Guidance.
        --  The FDA also continues to keep its COVID-19 Diagnostics FAQ up to

Additional Resources:

    --  Coronavirus Disease 2019 (COVID-19)

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration